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Janssen/Legendary Bio-CAR-T Therapy Completes Rolling Submission of FDA Biological Products License Application

 Last Update: 2021-05-03
 Source: Internet
 Author: User

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A few days ago, Legendary Biotech stated in the regulatory documents submitted to the US SEC that the company’s partner Janssen has completed the rolling submission to the US FDA for the B-cell maturation antigen (BCMA) CAR-T therapy ciltacabtagene autoleucel ( cilta-cel) Biologics License Application (BLA) for the treatment of adult patients with relapsed/refractory multiple myeloma.

Multiple myeloma (MM) is an incurable blood cancer caused by canceration of white blood cells called plasma cells.

Cilta-cel is a CAR-T cell therapy with a differential structure.

The latest clinical data released at the annual meeting of the American Society of Hematology held last year showed that cilta-cel continued to show a very high overall response rate (ORR) in the phase 1b/2 clinical trial called CARTITUDE-1, at a median At the follow-up time of 12.

A few days ago, Abecma (idecabtagene vicleucel), jointly developed by Bristol-Myers Squibb (BMS) and bluebird bio, was approved by the FDA and became the first cell therapy targeting BCMA.

Reference materials:

[1] Form 20-F, Legend Biotech Corporation, Retrieved April 5, 2021, from

[1] Form 20-F, Legend Biotech Corporation, Retrieved April 5, 2021, fromclass="MsoNormal" style="text-align:center;"> ▽ attention [drug Mingkang Germany ] micro-channel public number

[Medical attention Mingkang Germany ] ] micro-channel public number

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